Recall Enforment Report D-0691-2017

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Meridian Medical Technologies a Pfizer Company, originally initiated on 03-12-2017 for the product EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company. The product was recalled due to defective delivery system; reports of the device failing to activate which could result in a patient not receiving medication. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0691-201703-12-201705-10-2017Class I92,544 2-pak (U.S.); 198,579 syringes (O.U.S.)EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medicationOngoing
D-0690-201703-12-201705-10-2017Class I373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.)EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medicationOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
49502-500Epipen EpinephrineInjectionIntramuscularViatris Specialty LlcHuman Prescription Drug
49502-501Epipen Jr EpinephrineInjectionIntramuscularViatris Specialty LlcHuman Prescription Drug